(76 days)
The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
The Glidesheath Slender consists of an introducer sheath and a dilator which are packaged together with an entry needle and mini guide wire. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth. making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.
The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in two versions, either a stainless steel needle or a Surflo IV catheter (K891087).
The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in two versions, either a stainless steel (spring coil) model or a polyurethane (nitinol core) plastic model.
A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.
The provided 510(k) summary describes the Glidesheath Slender, a catheter introducer. This document focuses on demonstrating substantial equivalence to a predicate device (Terumo Glidesheath K082644) through performance testing, material comparison, and biocompatibility evaluations, rather than reporting on a study measuring a specific clinical outcome with defined acceptance criteria for device performance.
Therefore, many of the requested sections related to acceptance criteria, device performance, expert-established ground truth, MRMC studies, standalone performance, and training/test set details are not applicable as this is a submission for a medical device that relies on bench testing and material equivalency, not an AI/software as a medical device (SaMD).
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria or quantifiable device performance results for clinical outcomes. Instead, it lists various performance tests conducted according to ISO standards and internal standards to verify substantial equivalence to the predicate device. The implied acceptance criterion for each test is that the Glidesheath Slender performs adequately and comparably to the predicate device, thereby ensuring safety and effectiveness.
Table of Performance Tests and General Outcome (as inferred from the document):
| Performance Testing (Sheath) | Method | Implied Acceptance Criteria / Outcome |
|---|---|---|
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 7.2 | Dimensions within specified tolerances; comparable to predicate. |
| Freedom from leakage (sheath) | ISO 11070 Sec. 7.3 | No leakage; comparable to predicate. |
| Freedom from leakage (hemostasis valve) | ISO 11070 Sec. 7.4 | No leakage; comparable to predicate. |
| Force at break (sheath) | ISO 11070 Sec. 7.6 | Meets strength requirements; comparable to predicate. |
| Force at break (sheath to hub) | ISO 11070 Sec. 7.6 | Meets strength requirements; comparable to predicate. |
| Sheath to dilator fit | ISO 11070 Sec. A.1 | Proper fit; comparable to predicate. |
| Rollback test | ISO 11070 Sec. A.1 | Demonstrates adequate coating adhesion/stability; comparable to predicate. |
| Puncture model test | ISO 11070 Sec. A.1 | Demonstrates appropriate performance upon insertion; comparable to predicate. |
| Flexibility (kink angle) | ISO 11070 Sec. A.1 | Meets flexibility requirements; comparable to predicate. |
| Flexibility (radius of curvature) | ISO 11070 Sec. A.1 | Meets flexibility requirements; comparable to predicate. |
| Catheter insertion resistance | Internal Standard | Low resistance comparable to predicate. |
| Penetration resistance | Internal Standard | Appropriate resistance; comparable to predicate. |
| External surface sliding performance | Internal Standard | Smooth sliding; comparable to predicate. |
| Hydrophilic coating separation resistance | Internal Standard | Coating remains intact; comparable to predicate. |
| Hydrophilic coating particulate evaluation | FDA Guidance, USP788 | Meets particulate limits; comparable to predicate. |
| Performance Testing (Dilator) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 9.2 | Dimensions within specified tolerances; comparable to predicate. |
| Conical fitting | ISO 11070 Sec. 9.3.2, ISO 594-1 | Proper conical fit; comparable to predicate. |
| Strength of union (dilator to hub) | ISO 11070 Sec. 9.3.3 | Meets strength requirements; comparable to predicate. |
| Performance Testing (Stainless Steel Needle) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 5.2 | Dimensions within specified tolerances; comparable to predicate. |
| Needle point | ISO 11070 Sec. 5.3 | Sharp and properly formed; comparable to predicate. |
| Conical fitting | ISO 11070 Sec. 5.4.1, ISO 594-1 | Proper conical fit; comparable to predicate. |
| Strength of union (needle tube to hub) | ISO 11070 Sec. 5.4.2 | Meets strength requirements; comparable to predicate. |
| Performance Testing (Surflo IV Needle) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 5.2 | Dimensions within specified tolerances; comparable to predicate. |
| Needle point | ISO 11070 Sec. 5.3 | Sharp and properly formed; comparable to predicate. |
| Conical fitting | ISO 11070 Sec. 5.4.1, ISO 594-1 | Proper conical fit; comparable to predicate. |
| Strength of union (needle tube to hub) | ISO 11070 Sec. 5.4.2 | Meets strength requirements; comparable to predicate. |
| Performance Testing (Surflo IV Catheter) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Catheter to needle fit | ISO 11070 Sec. 6.2 | Proper fit; comparable to predicate. |
| Strength of union (catheter to hub) | ISO 11070 Sec. 6.3 | Meets strength requirements; comparable to predicate. |
| Conical fitting | ISO 11070 Sec. 6.4, ISO 594-1 | Proper conical fit; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 6.5 | Dimensions within specified tolerances; comparable to predicate. |
| Performance Testing (Plastic Guide Wire) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 8.2 | Dimensions within specified tolerances; comparable to predicate. |
| Test for fracture of guide wire | ISO 11070 Sec. 8.4 | Resistant to fracture; comparable to predicate. |
| Resistance to damage by flexing | ISO 11070 Sec. 8.5 | Resistant to damage from flexing; comparable to predicate. |
| Performance Testing (Stainless Steel Guide Wire) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 8.2 | Dimensions within specified tolerances; comparable to predicate. |
| Test for fracture of guide wire | ISO 11070 Sec. 8.4 | Resistant to fracture; comparable to predicate. |
| Resistance to damage by flexing | ISO 11070 Sec. 8.5 | Resistant to damage from flexing; comparable to predicate. |
| Strength of union of safety wire and coil | ISO 11070 Sec. 8.6 | Meets strength requirements; comparable to predicate. |
| Strength of union of core wire and coil | ISO 11070 Sec. 8.7 | Meets strength requirements; comparable to predicate. |
| Biocompatibility | ISO 10993-1:2009 | Classified as Externally Communicating Devices, Circulating Blood, Limited Contact (<24 hrs); identical to predicate. |
| Sterilization | ANSI/AAMI/ISO 11135 | Sterility Assurance Level (SAL) of 10^-6 achieved. Residual EO/ECH meet ISO 10993-7 requirements. |
| Non-pyrogenic | USP <85> Bacterial Endotoxins Test, FDA Guideline (1987) | Certified non-pyrogenic; LAL test performed on each lot; validation performed per FDA guideline. |
| TiO2 Particle Release | ISO10993-12 | Potential release much lower than tolerable intake (NOAEL); no safety concern. |
The "reported device performance" is implicitly that the device successfully met all these technical and biological safety requirements, thereby demonstrating substantial equivalence to the predicate device.
2. Sample size(s) used for the test set and the data provenance
The document refers to "bench tests" and "each lot of production" for LAL tests. It does not specify a distinct "test set" in the context of patient data. The tests are focused on component and assembly performance, material properties, and sterilization, typically involving a representative number of units or material samples from manufacturing lots. No patient data or clinical data is mentioned for these performance tests.
- Test Set Sample Size: Not specified in the context of patient data; applies to manufactured units/samples for bench testing.
- Data Provenance: Not applicable as these are bench tests and laboratory evaluations, not data from a specific country of origin or retrospective/prospective patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device's evaluation relies on established engineering standards, biocompatibility protocols, and manufacturing quality controls, not an expert consensus on a "ground truth" derived from patient cases.
4. Adjudication method for the test set
Not applicable. No expert adjudication process is described for these types of performance tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/SaMD device, and therefore, an MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/SaMD device.
7. The type of ground truth used
The "ground truth" for this device's evaluation is defined by established engineering specifications, material composition standards, ISO/FDA recognized test methods, and biocompatibility requirements. For instance, the ground truth for "Dimensional verification" is the specified blueprint dimensions, and for "Corrosion resistance," it's the absence of corrosion under specified conditions.
8. The sample size for the training set
Not applicable. This is not an AI/SaMD device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or corresponding ground truth.
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510(K) SUMMARY
DEC 1 1 2012
ﺩ \ ﻣﻤﺴ
K122980 P
A. Device Name
| Proprietary Name | Glidesheath Slender |
|---|---|
| Classification Name | Catheter Introducer (as per 870.1340) |
| Common Name | Introducer Sheath |
| Product Code | DYB |
B. Intended Use
The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
C. Predicate Device
Terumo Corporation, Glidesheath (K082644)
D. Device Description
The Glidesheath Slender consists of an introducer sheath and a dilator which are packaged together with an entry needle and mini guide wire. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth. making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.
The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in two versions, either a stainless steel needle or a Surflo IV catheter (K891087).
The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in two versions, either a stainless steel (spring coil) model or a polyurethane (nitinol core) plastic model.
A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.
E. Principle of Operation
The Glidesheath Slender is operated manual process. This is the same principle of operation of the predicate Glidesheath device.
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F. Technological/Design Comparison
- §¡ႁ̣̣ The Giligẹsheath Slender submitted in this 510(k) and the Glidesheath cleared under K082644 contain the same basic components. Specification differences do not raise any new issues of safety and effectiveness.
KI2298
| Specification | Glidesheath(K082644) | Glidesheath Slender |
|---|---|---|
| Sheath Sizes | 4, 5 and 6Fr | 6Fr |
| Sheath Tip ID (6Fr) | 2.10mm | 2.10mm |
| Sheath OD (6Fr) | 2.62mm | 2.46mm |
| Sheath Length | 10, 16 and 25cm | 10 and 16cm |
| Sheath Coating | Hydrophilic | Hydrophilic |
| (entire length of shaft) | (entire length of shaft) | |
| Dilator Length | 15.5cm - 30.5cm | 15.5cm - 21.5cm |
| Stainless Steel Guide Wire OD | .021" - . 038" | .018" - .035" |
| Stainless Steel Guide Wire Length | 10cm -180cm | 45cm - 80cm |
| Plastic Guide Wire OD | .021" - . 038" | .018" - 035" |
| Plastic Guide Wire Length | 45cm - 80cm | 45cm - 80cm |
| Metallic Entry Needle Size | 20G - 21G | 20G - 22G |
| Metallic Entry Needle Length | 1.5" | 1.5" |
| Surflo IV Catheter Size | 16G - 22G | 18G - 22G |
| Surflo IV Catheter Length | 1" -- 2.5" | l" – 2.5" |
G. Materials Comparison
The Glidesheath Slender submitted in this 510(k) and the Glidesheath cleared under K082644 are manufactured from identical materials.
| Component | Glidesheath(K082644) | GlidesheathSlender |
|---|---|---|
| Sheath Tubing | ETFE, Bismuth | ETFE, Bismuth |
| Hydrophilic Coating | Dimethyl acrylamide-glycidylmethacrylate copolymer | Dimethyl acrylamide-glycidylmethacrylate copolymer |
| Sheath Housing | Polypropylene | Polypropylene |
| Sheath Caulking Pin | Stainless Steel | Stainless Steel |
| Sheath Cap | Polypropylene | Polypropylene |
| Sheath Valve | Silicone Rubber | Silicone Rubber |
| Sheath Support | Styrene-ethylene-butylene-styrene block copolymer | Styrene-ethylene-butylene-styrene block copolymer |
| Side Tube | Polybutadiene | Polybutadiene |
| 3-Way Stopcock | Polyethylene, Polypropylene,Polycarbonate | Polyethylene, Polypropylene,Polycarbonate |
| Dilator Tube | Polypropylene | Polypropylene |
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K122980 Page 3 of 6
| Dilator Hub | Polypropylene | Polypropylene |
|---|---|---|
| Dilator Caulking Pin | Stainless Steel | Stainless Steel |
| Plastic Guide Wire | NiTi, Tungsten, Polyurethane | NiTi, Tungsten, Polyurethane |
| Metallic Guide Wire | Stainless Steel | Stainless Steel |
| Guide inserter | Polyethylene | Polyethylene |
| Metallic Needle | Stainless Steel | Stainless Steel |
| Metallic Needle Hub | Styrene-butadiene copolymer | Styrene-butadiene copolymer |
| IV Catheter Tube | ETFE, Barium sulfate | ETFE, Barium sulfate |
| IV Catheter Hub | Polypropylene | Polypropylene |
| IV Catheter Caulking Pin | Stainless Steel | Stainless Steel |
| IV Catheter Filter Cap | Polystyrene, Polyester- | Polystyrene, Polyester- |
| Chlorinated polyethylene | Chlorinated polyethylene | |
| IV Catheter Adapter | Polypropylene | Polypropylene |
| IV Catheter Needle | Stainless Steel | Stainless Steel |
| IV Catheter Needle Hub | Polycarbonate | Polycarbonate |
H. Performance Testing
The following bench tests were performed to verify that the subject device is substantially equivalent to the predicate device and that there are no new issues regarding the safety and effectiveness of the device:
| Performance TestingSheath | Method |
|---|---|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Dimensional verification | ISO 11070 Sec. 7.2 |
| Freedom from leakage (sheath) | ISO 11070 Sec. 7.3 |
| Freedom from leakage (hemostasis valve) | ISO 11070 Sec. 7.4 |
| Force at break (sheath) | ISO 11070 Sec. 7.6 |
| Force at break (sheath to hub) | ISO 11070 Sec. 7.6 |
| Sheath to dilator fit | ISO 11070 Sec. A.1 |
| Rollback test | ISO 11070 Sec. A.1 |
| Puncture model test | ISO 11070 Sec. A.1 |
| Flexibility (kink angle) | ISO 11070 Sec. A.1 |
| Flexibility (radius of curvature) | ISO 11070 Sec. A.1 |
| Catheter insertion resistance | Internal Standard |
| Penetration resistance | Internal Standard |
| External surface sliding performance | Internal Standard |
| Hydrophilic coating separation resistance | Internal Standard |
| Hydrophilic coating particulate evaluation | FDA Guidance', USP788 |
1 Class II Special Controls Guidance Document for Certain Perculaneous Transluminal Coronary Angioplasty (PTCA) Catheters
{3}------------------------------------------------
| Performance TestingDilator | Method |
|---|---|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Dimensional verification | ISO 11070 Sec. 9.2 |
| Conical fitting | ISO 11070 Sec. 9.3.2 |
| ISO 594-1 | |
| Strength of union (dilator to hub) | ISO 11070 Sec. 9.3.3 |
| Performance TestingStainless Steel Needle | Method |
|---|---|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Dimensional verification | ISO 11070 Sec. 5.2 |
| Needle point | ISO 11070 Sec. 5.3 |
| Conical fitting | ISO 11070 Sec. 5.4.1, ISO 594-1 |
| Strength of union (needle tube to hub) | ISO 11070 Sec. 5.4.2 |
| Performance TestingSurflo IV Needle | Method |
|---|---|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Dimensional verification | ISO 11070 Sec. 5.2 |
| Needle point | ISO 11070 Sec. 5.3 |
| Conical fitting | ISO 11070 Sec. 5.4.1, ISO 594-1 |
| Strength of union (needle tube to hub) | ISO 11070 Sec. 5.4.2 |
| Performance TestingSurflo IV Catheter | Method |
|---|---|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Catheter to needle fit | ISO 11070 Sec. 6.2 |
| Strength of union (catheter to hub) | ISO 11070 Sec. 6.3 |
| Conical fitting | ISO 11070 Sec. 6.4, ISO 594-1 |
| Dimensional verification | ISO 11070 Sec. 6.5 |
| Performance TestingPlastic Guide Wire | Method |
|---|---|
| Surface | ISO 11070 Sec. 4.3 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Dimensional verification · | ISO 11070 Sec. 8.2 |
| Test for fracture of guide wire | ISO 11070 Sec. 8.4 |
| Resistance to damage by flexing | ISO 11070 Sec. 8.5 |
{4}------------------------------------------------
| Performance TestingStainless Steel Guide Wire | Method |
|---|---|
| Surface | ISO 11070 Sec. 4.3 |
| Corrosion resistance | ISO 11070 Sec. 4.4 |
| Radiodetectability | ISO 11070 Sec. 4.5 |
| Dimensional verification | ISO 11070 Sec. 8.2 |
| Test for fracture of guide wire | ISO 11070 Sec. 8.4 |
| Resistance to damage by flexing | ISO 11070 Sec. 8.5 |
| Strength of union of safety wire and coil | ISO 11070 Sec. 8.6 |
| Strength of union of core wire and coil | ISO 11070 Sec. 8.7 |
I. Biocompatibility
Biocompatibility of Glidesheath Slender was evaluated based on ISO10993-1 : 2009. The Glidesheath Slender including Sheath, Dilator, Guidewire, and Entry needle are classified as Externally Communicating Devices, Circulating Blood, Limited Contact (<24 hrs). This is the same classification as the predicate Glidesheath (K082644).
All of the materials and manufacturing processes used to fabricate the Glidesheath Slender are identical to the Glidesheath predicate device cleared in K082644.
Glidesheath Slender has the same body contact, contact duration, blood contacting materials, manufacturing processes and sterilization method as the Glidesheath predicate device (K082644). Additionally, the Glidesheath product line has a demonstrated history of safe and effective use. We conclude therefore that the Glidesheath Slender is biocompatible for its intended use.
J. Sterilization
Sterilization conditions have been validated according to ANSI / AAMI / ISO 11135. Sterilization of Health Care Products- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6.
Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals will meet requirements for limited exposure devices (contact up to 24 hours) prior to use, based on ISO 10993-7. Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization residuals. Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device.
K. Additional Safety Information
The Glidesheath Slender is certified to be non-pyrogenic in the unopened and undamaged package. Kinetic Turbidimetric Limulus Amebocyte Lysate (LAL) test is performed on each lot of production in accordance with the United States Pharmacopoeia (USP) <85> Bacterial Endotoxins Test. Validation was performed in accordance with FDA published "Guideline on
{5}------------------------------------------------
Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices"; 1987.
13122880
Potential release of TiO2 particles from the Glidesheath Slender was evaluated using both nonpolar and polar extracts in accordance with ISO10993-12. Results demonstrated that potential release of titanium dioxide per product was much lower than the tolerable intake calculated from the No Observable Adverse Effect Level (NOAEL) and therefore, does not raise a safety concern.
L. Substantial Equivalence
The Glidesheath Slender is substantially equivalent in intended use, principles of operation, design/technology, materials and performance to the predicate device the Glidesheath (K082644). Differences between the devices do not raise any new concerns of safety or effectiveness.
M. Submitter Information
| Prepared By: | Mr. Daniel R. Plonski, RACSr. Regulatory Affairs Specialist |
|---|---|
| Prepared For: | Terumo Medical Corporation950 Elkton Blvd.Elkton, MD 21921Phone: (410) 392-7395Fax: (410) 398-6079Email: daniel.plonski@terumomedical.com |
Date Prepared: September 25, 2012
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Image /page/6/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a stylized representation of a bird or wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 1 1 2012
Terumo Medical Co. Daniel Plonski, Senior Regulatory Affairs Specialist 950 Elkton Blvd Elkton, MD 21921
Re: K122980
Trade/Device Name: Glidesheath Slender introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 25, 2012 Received: September 26, 2012
Dear Daniel Plonski,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{7}------------------------------------------------
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Matthew G. Hillebrenner
for
Bram Zuckerman, M.D. Director -Division of Cardiac Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ K/22 980
Glidesheath Slender™ Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cmgsttllle
on of Cardiovascular Devices
510(k) Number K122980
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).